Hays posted a job you might be interested in June 30, 2014 at 10:56AM

Hays



Change Management Analyst

Amsterdam Area, Netherlands, NL - Medical Devices

We are currently looking for a Regulatory Affairs Manager for a temporary period of 5 months (with possible extension) due to maternity leave. The purpose of this position is to obtain international market access for our innovative medical applications. This is done by defining smart clinical and regulatory strategies, and by first time right submissions to the FDA, Notified Body and Health Canada.



Responsibilities:

-Define clinical and regulatory strategies for mainly standalone software medical products in the field of interventional XR;

-Assure the quality of the clinical evaluation report and the technical file by guiding the responsible disciplines;

-Compile the submission files and obtain approvals in the USA (510(k)), Canada and Europe (MDD);

-Make the technical file available for submissions in the rest of the world, and support our colleagues in obtaining the local approvals;

-Monitor the global regulatory developments and deploy these new or updated requirements via the BMS and/or training and coaching;

-Assists in RA activities related to our fixed systems and innovation activities.

No salary provided



Posted June 30, 2014 at 10:56AM from LinkedIn http://ift.tt/1lIhwF4

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